CClinicalTrials.gg
RecruitingNCT05692609Updated Jan 8, 2024

The Effect of Implant-supported Prosthesis on Acoustic Voice Quality

An observational study in Edentulous Jaw, sponsored by Marmara University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.

Sponsored by Marmara University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The primary aim of this study was to compare the acoustic sound quality of edentulous patients rehabilitated with two-implant overdentures or the all-on-4 concept. The secondary aims were to evaluate the effect of implant and prosthetic success on acoustics.

02

Conditions studied

  • Edentulous Jaw

Keywords

  • Dental Prosthesis, Implant-Supported
  • Speech Acoustics
03

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 25 observational studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with all-on-4 or two-implant overdentures whose surgery and prosthesis were performed at Marmara University Faculty of Dentistry clinics

Inclusion criteria

  • No voice disorder or speech therapy
  • The implant prosthesis was made at least one year ago, delivered to the patient, and continues to be used

Exclusion criteria

Exclusion Criteria:

  • Smoking (>10 cigarettes/day) or substance use
  • History of acute or chronic respiratory diseases
  • Overdenture prosthesis on three or 4 implants
  • History of speech and hearing problems
  • Patients who have lost any implants before the control
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Implant overdenture group

    In the control session, participants' acoustic sound quality, implant and prosthesis success will be measured.

  • All-on-4 group

    In the control session, participants' acoustic sound quality, implant and prosthesis success will be measured.

06

What researchers measure

Primary outcomes

  1. Acoustic voice quality index

    The acoustic Voice Quality Index (AVQI) measures the perceived quality of a voice signal. It is based on evaluating several acoustic parameters that are known to be related to the perceived quality of speech. These parameters include measures of loudness, pitch, and spectral tilt, as well as measures of the presence of noise and other distortions in the signal. Acoustic voice quality will be evaluated in accordance with the AVQI index. During the control session, two separate voice recordings will be made with and without the participants' dentures in the mouth and transferred to the software. The score obtained according to the AVQI index will be used for statistical analysis between groups.

    Time frame: At the follow-up session (approximately one year after delivery of the prosthesis)

Secondary outcomes

  1. Implant success

    Implant success will be defined according to the following criteria: * Clinical stability and immobility (0); (1) * Full functionality (0); (1) * Absence of pain on mild percussion (0); (1) * Healthy peri-implant soft tissue and radiolucency at probing (0); (1) * Absence of other radiographic pathologic conditions (0); (1). Implant loss and implant mobility will be recorded on standardized documentation forms, as will complications related to prostheses.

    Time frame: At the follow-up session (approximately one year after delivery of the prosthesis)

  2. Prosthetic Success

    The success of the prosthetic treatment will be evaluated according to the criteria set by Awad and Feine. Participants will be asked about their overall satisfaction with their prosthesis. Also; * Prosthesis stability (0) - (10) * Comfort (0) - (10) * Chewing skills (0) - (10) * Speaking skills (0) - (10) * Ease of cleaning (0) - (10) and * They will be asked to rate their aesthetic appearance (Awad \& Feine, 1998). Participants will rate each item on a 10 cm visual analog scale, where the anchor words are "not at all satisfied" for zero and "completely satisfied" for 10. Participants will be asked to draw a vertical line at the point on the scale that best reflects their responses, where higher scores indicate greater satisfaction.

    Time frame: At the follow-up session (approximately one year after delivery of the prosthesis)

07

Study locations

1 of 1 sites recruiting
  • Marmara University School of Dentistry
    Istanbul, 34854, Turkey
    Recruiting
08

References and documents

Publications

  • Tyrovolas S, Koyanagi A, Panagiotakos DB, Haro JM, Kassebaum NJ, Chrepa V, Kotsakis GA. Population prevalence of edentulism and its association with depression and self-rated health. Sci Rep. 2016 Nov 17;6:37083. doi: 10.1038/srep37083. PubMed 27853193 ↗
  • Marcus PA, Joshi A, Jones JA, Morgano SM. Complete edentulism and denture use for elders in New England. J Prosthet Dent. 1996 Sep;76(3):260-6. doi: 10.1016/s0022-3913(96)90169-9. PubMed 8887798 ↗
  • Romandini M, Baima G, Antonoglou G, Bueno J, Figuero E, Sanz M. Periodontitis, Edentulism, and Risk of Mortality: A Systematic Review with Meta-analyses. J Dent Res. 2021 Jan;100(1):37-49. doi: 10.1177/0022034520952401. Epub 2020 Aug 31. PubMed 32866427 ↗
  • Nowjack-Raymer RE, Sheiham A. Association of edentulism and diet and nutrition in US adults. J Dent Res. 2003 Feb;82(2):123-6. doi: 10.1177/154405910308200209. PubMed 12562885 ↗
  • Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014 Oct;93(10):959-65. doi: 10.1177/0022034514546165. Epub 2014 Aug 21. PubMed 25146182 ↗
  • Douglass CW, Watson AJ. Future needs for fixed and removable partial dentures in the United States. J Prosthet Dent. 2002 Jan;87(1):9-14. doi: 10.1067/mpr.2002.121204. PubMed 11807477 ↗
  • Malo P, Rangert B, Nobre M. "All-on-Four" immediate-function concept with Branemark System implants for completely edentulous mandibles: a retrospective clinical study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:2-9. doi: 10.1111/j.1708-8208.2003.tb00010.x. PubMed 12691645 ↗
  • Zitzmann NU, Scharer P, Marinello CP. Factors influencing the success of GBR. Smoking, timing of implant placement, implant location, bone quality and provisional restoration. J Clin Periodontol. 1999 Oct;26(10):673-82. doi: 10.1034/j.1600-051x.1999.261007.x. PubMed 10522779 ↗
  • Jacobs R, Manders E, Van Looy C, Lembrechts D, Naert I, van Steenberghe D. Evaluation of speech in patients rehabilitated with various oral implant-supported prostheses. Clin Oral Implants Res. 2001 Apr;12(2):167-73. doi: 10.1034/j.1600-0501.2001.012002167.x. PubMed 11251667 ↗
  • Lu FL, Matteson S. Speech tasks and interrater reliability in perceptual voice evaluation. J Voice. 2014 Nov;28(6):725-32. doi: 10.1016/j.jvoice.2014.01.018. Epub 2014 May 17. PubMed 24841668 ↗
  • Umapathy K, Krishnan S, Parsa V, Jamieson DG. Discrimination of pathological voices using a time-frequency approach. IEEE Trans Biomed Eng. 2005 Mar;52(3):421-30. doi: 10.1109/TBME.2004.842962. PubMed 15759572 ↗
  • Asiaee M, Nourbakhsh M, Vahedian-Azimi A, Zare M, Jafari R, Atashi SS, Keramatfar A. The feasibility of using acoustic measures for predicting the Total Opacity Scores of chest computed tomography scans in patients with COVID-19. Clin Linguist Phon. 2024 Mar;38(2):97-115. doi: 10.1080/02699206.2022.2160659. Epub 2023 Jan 2. PubMed 36592050 ↗
  • Shabnam S, Pushpavathi M, Gopi Sankar R, Sridharan KV, Vasanthalakshmi MS. A Comprehensive Application for Grading Severity of Voice Based on Acoustic Voice Quality Index v.02.03. J Voice. 2025 Jan;39(1):287.e1-287.e9. doi: 10.1016/j.jvoice.2022.08.013. Epub 2022 Oct 1. PubMed 36192290 ↗
  • Barsties V Latoszek B, Ulozaite-Staniene N, Petrauskas T, Uloza V, Maryn Y. Diagnostic Accuracy of Dysphonia Classification of DSI and AVQI. Laryngoscope. 2019 Mar;129(3):692-698. doi: 10.1002/lary.27350. Epub 2018 Sep 10. PubMed 30203473 ↗
  • Englert M, Barsties V Latoszek B, Maryn Y, Behlau M. Validation of the Acoustic Voice Quality Index, Version 03.01, to the Brazilian Portuguese Language. J Voice. 2021 Jan;35(1):160.e15-160.e21. doi: 10.1016/j.jvoice.2019.07.024. Epub 2019 Aug 29. PubMed 31474432 ↗
  • Faham M, Laukkanen AM, Ikavalko T, Rantala L, Geneid A, Holmqvist-Jamsen S, Ruusuvirta K, Pirila S. Acoustic Voice Quality Index as a Potential Tool for Voice Screening. J Voice. 2021 Mar;35(2):226-232. doi: 10.1016/j.jvoice.2019.08.017. Epub 2019 Sep 30. PubMed 31582330 ↗
  • Yesilli-Puzella G, Tadihan-Ozkan E, Maryn Y. Validation and Test-Retest Reliability of Acoustic Voice Quality Index Version 02.06 in the Turkish Language. J Voice. 2022 Sep;36(5):736.e25-736.e32. doi: 10.1016/j.jvoice.2020.08.021. Epub 2020 Sep 20. PubMed 32962941 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05692609
Lead sponsor
Marmara University
Responsible party
Ferit Bayram (Assist. Prof., Marmara University) — Principal investigator
First posted
Jan 20, 2023
Start date
Mar 1, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Jan 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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